For decades, standard practice at most Danish hospitals has been to prescribe pantoprazole, a stomach ulcer drug, as preventive stomach ulcer treatment for seriously ill intensive-care patients. However, new research spearheaded by the research unit at Rigshospitalet's Department of Intensive Care and the Danish Centre for Research in Intensive Care (CRIC) now shows that preventive stomach ulcer drugs do not help patients. Results of the SUP-ICU trial have just been published in the prestigious New England Journal of Medicine (NEJM).
Physicians at Rigshospitalet have already reacted to the new research results by discontinuing prescriptions of pantoprazole as a standard treatment for intensive-care patients, according to Morten Hylander Møller, Staff Specialist and Clinical Research Associate Professor, who co-headed the project with Consultant and Professor Anders Perner.
"The use of stomach ulcer medicine as preventive treatment started because some intensive-care patients developed bleeding ulcers. But the medicine has never been tested for this use. Our results show that the treatment does not help the patients, and, of course, then there is no reason to prescribe the drug," said Morten Hylander Møller.
Greater risk of medication errors
Overall, both the patients and the health-care sector benefit from avoiding prescribing unnecessary medication," explained Anders Perner.
"Pantoprazole can have side effects and adverse interactions with the many other drugs that patients in this group are often already taking. And the more medicine we administer, the greater the risk of medication errors," said Anders Perner.
In Denmark alone, every year 30,000 intensive-care patients become severely ill due to blood poisoning, severe pneumonia, trauma or a major operation. Three in four of these patients have been given stomach ulcer drugs as preventive treatment. For three decades, hospitals in Denmark and other countries have been using the medicine prophylactically on more and more patients, but without examining the effects and side effects.
Monitored for 90 days
Patients at intensive-care departments are critically ill with vital organ failure, and the mortality rate is around 25%. The SUP-ICU trial is the largest trial worldwide to systematically study preventive treatment of bleeding stomach ulcers in intensive-care patients.
The trial included 3,350 patients from 33 intensive-care departments, 19 of which were located at hospitals in Denmark. The patients were randomised to receive either preventive stomach ulcer medicine or a placebo. Subsequently, the patients were monitored for 90 days to examine whether they developed a bleeding stomach ulcer, severe side effects, and whether they survived.
The research project was conducted independently of the pharmaceutical industry with funding from Innovation Fund Denmark, the research councils at Rigshospitalet and the Capital Region of Denmark and from Danish Regions (Regionernes Medicinpulje), among others.
FACTS:Six clinical trials have revealed inappropriate medication
The purpose of CRIC is to investigate treatments for intensive-care patients in Denmark whenever there is uncertainty about the overall benefits or adverse effects. The Department of Intensive Care and CRIC have conducted six clinical trials, all of which have shown that it would be an advantage to cut down on medication:
The 6S trial: Hydroxyethyl starch (HES) or saltwater to treat blood poisoning: Fewer deaths, and lower use of dialysis and blood with saltwater.
TRISS trial: Liberal versus restrictive blood transfusion: No difference in treatment results, but the restrictive transfusion strategy resulted in clearly lower consumption of blood, and fewer patients needed transfusion.
INSTINCT trial: Immunoglobulin (antibodies) or placebo (saltwater) for treatment of severe soft tissue infection: No difference in treatment results, so it has been possible to substantially reduce consumption of immunoglobulin, which is an expensive and scarce resource.
EAT-ICU trial: Early targeted intravenous (IV) nutrition or standard nutrition: No difference in treatment results, so it has been possible to reduce consumption of expensive IV nutrition products.
CLASSIC trial: Standard fluid treatment or more restrictive IV fluid administration: No clear difference in treatment results leading to a reduction in consumption of IV fluid.
SUP-ICU trial: Preventive stomach ulcer medicine or placebo: Preventive stomach ulcer medicine has no benefits for patients.